CN115697478A

CN115697478A - Stimulation device and method of activating a patient

Info

Publication number: CN115697478A
Application number: CN202180041008.0A
Authority: CN
Inventors: R·米勒-布鲁恩
Original assignee: Stimit AG
Current assignee: Stimit AG
Priority date: 2020-04-09
Filing date: 2021-04-09
Publication date: 2023-02-03
Also published as: JP2023520718A; EP4132644A1; WO2021204981A1; US20230173290A1; CA3174471A1; KR20230005145A

Abstract

A stimulation device (1) comprises a sensing device (2) having a field generator (21) configured to generate a spatial field having a target shape, and a control unit (3), the control unit (3) being in communication with the sensing device (2) and configured to control the sensing device (2) to generate the spatial field. The field generator (21) of the induction device (2) is configured to be placed at a human or animal patient (5) such that upon activation of the patient (5) the target tissue is stimulated by the spatial field generated by the coil design. The control unit (3) is configured to operate the induction device (2) such that the field generator (21) generates a train of consecutive sequences of a plurality of pulses of the electromagnetic field, wherein the sequence is intermittent.

Description

Stimulation device and method of activating a patient

Technical Field

The present invention relates to a stimulation device according to the preamble of independent claim 1, and more particularly to a method of manufacturing such a stimulation device, to a method of activating a patient, and to a computer program for controlling the activation of a patient.

Background

In medicine, it is well known that for different treatment methods it is beneficial to activate the patient, i.e. to activate the muscle or similar structure of the patient. Therefore, it is generally intended to activate the patient by stimulating the target tissue with an electromagnetic field. For example, in therapeutic applications of the knee joint after surgical treatment, it is known to activate muscles around the knee joint by directly stimulating the muscles with an electromagnetic field. For such activation, it is known to place a specific stimulation device at the patient and generate an electromagnetic field.

In another exemplary field, particularly in intensive care units of hospitals, it may be necessary to activate the diaphragm of ventilated (ventilated) patients to prevent the disadvantages of a diaphragm being disabled. For example, studies have shown that in the first 18-69 hours of mechanical ventilation, disuse atrophy of the membrane fibers occurs and that over this time the muscle fiber cross-section is reduced by more than 50%. Therefore, there is a need to repeatedly activate the diaphragm while providing artificial or mechanical breathing to the patient so that the function of the diaphragm is maintained, or at least during off-line (bathing), to support effective restoration of the independent breathing function.

To achieve such activation of tissue in a patient, as described above, it is known to stimulate tissue directly or indirectly by stimulating specific parts of the nervous system. For example, tissue that is muscle tissue may be activated by providing an electrical pulse directly to the tissue or to a nerve associated with the tissue. More specifically, it is known to activate the diaphragm by stimulating the diaphragm nerve, for example, in the neck of a patient.

Even if such activation is known to the patient, it tends to induce discomfort to the patient. For example, sudden provision of electromagnetic stimulation may cause the patient's body to elicit a reactive response, such as a twitch or similar response, which may hinder the therapeutic effect. Moreover, electromagnetic stimulation often involves the generation of noise, which can affect patient comfort.

Accordingly, there is a need for a device, system or method that allows for relatively convenient and effective activation of a patient through stimulation by an electromagnetic field, and more particularly, allows for effective activation of a septum during ventilation of a patient.

Disclosure of Invention

According to the present invention, this need is solved by a stimulation device as defined by the features of independent claim 1, a method for manufacturing a stimulation device as defined by the features of independent claim 19, a method for activating a human or animal patient as defined by the features of independent claim 20 and a computer program as defined by the features of independent claim 40. Preferred embodiments are the subject of the dependent claims.

In one aspect, the present invention is a stimulation device that includes a sensing device and a control unit. The inductive device has a field generator configured to generate a spatial field having a target shape. The control unit is in communication with the sensing device and is configured to control the sensing device to generate the spatial field. The field generators of the induction device are configured to be positioned at a human or animal patient such that upon activation of the patient, target tissue is stimulated by the spatial fields generated by the field generators. The control unit is further configured to operate the induction device such that the field generator generates a train of continuous sequences of a plurality of pulses of the spatial field, wherein the sequences are discontinuous.

In the context of the present invention, activation of a patient relates to activation of any specific tissue of the patient's body, such as muscle tissue or the like. Thus, the tissue may be directly activated by stimulating the tissue itself. In this configuration, the tissue to be activated and the target tissue are the same. Alternatively or additionally, the tissue may also be activated indirectly, for example, in particular by a part of the nervous system of the patient. The stimulation device is particularly advantageous for indirectly activating the diaphragm of a patient by stimulating the diaphragm nerve of the patient as a target tissue.

The term "spatial field" in the context of aspects of the invention described below refers to any field that allows stimulation of a patient's target tissue. In particular to electric, magnetic or electromagnetic fields. Such fields allow for direct stimulation of muscle structures or indirect stimulation of muscle structures through the nervous system or through other muscle structures.

The target shape of the spatial field may be achieved by the spatial field being locally limited (i.e. having peaks). It is adapted to be active in a target region, which is a nerve region or tissue region that should be activated by a spatial field (e.g. the phrenic nerve that should be activated), such stimulation may for example be achieved by the peaks (focal regions) of the spatial field. The target shape is generally any shape of spatial field or time-varying field component that allows for effective stimulation of one or more target nerves while minimizing peripheral, above, or nearby blocking or other undesirable co-stimulation effects of the nerves. The peak shape is an example of this because it maximizes the effect of the focus area and minimizes the effect outside this area.

The term "pulse" in connection with the present invention refers to a relatively short spatial field supply. A single pulse thus involves the generation of a spatial field in a relatively short time and a relatively long interruption between two subsequent pulses. Typically, the frequency of the single pulse is below 10 hertz (Hz), such as 5 Hz or less, or the single pulse is initiated by the user or physician. The single pulse has a temporal width of about 10 microseconds (μ s) to about 300 μ s. Such impulses may activate nerve and muscle structures and may be recognized by the patient or sensors. In particular, such a single pulse may cause a single twitch (convulsion) of a muscle or muscle structure.

In contrast, when generated as a sequence rather than as a single pulse, the spatial fields are generated continuously or in the form of pulse sequences which follow one another relatively quickly. The frequency of such pulses ranges between about 15 hertz to about 30 hertz. Each of the plurality of pulses of the sequence preferably comprises substantially the same pulse time width, as previously described, a relatively short time width. More specifically, the pulse time width is preferably between about 160 microseconds to about 220 microseconds.

In particular, the sequence may serve the purpose of activating nerves or muscles, thereby inducing tonic contraction or activation. Advantageously, as described below, the sequence is provided by increasing the intensity (field strength) and/or frequency until the target intensity and frequency are reached (ramp protocol). This may reduce sudden twitches or discomfort. All these parameters are generalized to "temporal characteristics" or "temporal parameters" of the spatial field. These time parameters may be adjusted manually via the input interface or automatically controlled by an adjustment mechanism or control unit.

Parameters such as the voltage or current waveforms used to generate the spatial field can affect the temporal characteristics of the spatial field, including pulse shape, amplitude, width, polarity, and repetition frequency; the duration and interval of a burst or sequence of pulses; the total number of pulses; as well as the interval of the stimulation sessions and the total number of sessions, have an effect on, among other things, the field intensity and decide whether and at what intensity or dose to activate the target area or tissue.

The term "sequence" in the context of the present invention refers to a succession of a plurality of pulses involved. In particular, a single one of these sequences typically comprises a set of pulses. Thus, each of the sequences preferably comprises the same or at least a similar number of pulses. In other words, the groups of pulses comprised by each single sequence may consist of the same number of pulses. Furthermore, each of the sequences preferably comprises substantially the same sequence temporal width. More specifically, the sequence time width is preferably between about 0.5 seconds to about 1.5 seconds. Such a pulse sequence allows for stimulation of the target tissue, thereby effectively activating the patient.

In a preferred embodiment, the field generators of the induction device comprise electrodes and the spatial fields generated by the field generators are electric fields.

In a further preferred embodiment, the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electromagnetic field. As used herein, the term "coil design" may be or include at least two coils, or at least one coil of a conical or other curved or bulged shape, or at least one non-planar coil of a cylindrical or other shape, or at least one small coil, i.e. a coil small enough to generate a sharp electromagnetic field, e.g. a coil of 3cm or less in diameter. The target shape of the electromagnetic field described herein may include a peak formed by the spatial electromagnetic field. The electromagnetic field generator may also be referred to as an electromagnetic field creator.

The coil design of the electromagnetic field generator allows the electromagnetic field to be formed or customized according to the intended application of the ventilator. In particular, the target shape may be created to have a considerable sharpness. This allows for the specific stimulation of the nervous system or specific parts thereof. In particular, it allows for the specific stimulation of nerves such as the phrenic nerve and reduces or prevents the stimulation of other tissues or nerves beside, around or above the target nerve. To stimulate both phrenic nerves of the neck, a coil design featuring a double coil, a parabolic coil or a small circular coil that creates a focal electron field region may be provided.

The terms "positioned at" or "held at" as used in connection with a field generator of a sensing device refer to the field generator being in physical contact with or being held at a close distance from the patient's body. Thus, the position and orientation of the magnetic field generator or its component parts may be predefined or differentiated to suit the stimulation of the target tissue. To be configured to be positioned in a suitable location, the field generator may be formed to fit the location. Furthermore, it may be provided with suitable mounting structures to secure in this position.

For a control unit communicating with any other component, it may be connected to the other component by wire or wirelessly. In this way, control signals may be sent to other components for operation or control. Additionally or alternatively, signals such as sensor signals may be received by the control unit. For example, such sensor signals may represent a sensed dimension or physical characteristic, e.g. for further evaluation.

The control unit may be any computing entity adapted to perform the tasks involved in controlling the sensing device and ultimately for data evaluation and other purposes. It may be or include a laptop computer, desktop computer, server computer, tablet computer, smart phone, or the like. The term "control unit" includes both single devices as well as combination devices. For example, the control unit may be a distributed system, such as a cloud solution, performing different tasks at different locations.

Generally, a control unit or a computer relates to a processor or a Central Processing Unit (CPU), a permanent data storage having a recording medium such as a hard disk, a flash memory, or the like, a Random Access Memory (RAM), a Read Only Memory (ROM), a communication adapter such as a Universal Serial Bus (USB) adapter, a Local Area Network (LAN) adapter, a Wireless Local Area Network (WLAN) adapter, a bluetooth adapter, or the like, and a physical user interface such as a keyboard, a mouse, a touch screen, a microphone, a speaker, or the like. The control unit or computer may be embodied in a wide variety of components.

The control unit may be partly or wholly embodied as a separate component or as a component integrated in another device or component. For example, the control unit or components thereof may be embodied in a ventilator for ventilating a patient, and/or in a sensing device.

Operating the sensing device can involve, inter alia, inducing the sensing device to apply a spatial field to stimulate a target tissue, such as one phrenic nerve or both phrenic nerves of a patient. Thus, the control unit may activate the diaphragm of the patient by operating the sensing means.

By operating the sensing device to produce a continuous series of intermittent sequences, the stimulation can be adjusted in a complex manner according to the needs and requirements given in a particular therapy. For example, such a configuration allows for the integration of stimulation of septum activation in traditional ventilation applications. In this way, ventilation can be conveniently supported by the stimulation device, and the disadvantages of purely mechanical ventilation can be reduced. Thus, the stimulation device according to the invention may activate the patient relatively conveniently and efficiently.

Preferably, the plurality of pulses of each of the sequences comprises a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity. In this connection, the first pulse is the first pulse of the corresponding pulse train. The largest pulse is the last pulse of the corresponding pulse train and may be any pulse following the first pulse of the train. Furthermore, there may be multiple pulses of maximum intensity in a single sequence.

The term "intensity" used in connection with one of the pulses refers to the field strength of the spatial field generated in the respective pulse. Field strength generally refers to the magnitude of a vector-valued field, which can be measured in volts/meter for electric fields and amps/meter for magnetic fields. Providing an electromagnetic field as a spatial field may produce both electric and magnetic field strengths. However, in the electromagnetic field, one of the electric field strength or the magnetic field strength is negligible.

The intensity of the intermediate pulse between the first pulse and the maximum pulse preferably rises from the first pulse to the maximum pulse. This configuration of sequences allows for increased patient convenience. In particular, by having a lower intensity at the beginning, each sequence may achieve an adjustment to the patient with a relatively smooth start. This smooth onset is comparable to the natural motion of activated tissue. In this way, jerks and discomfort can be prevented, and the effect of activation can be increased.

Additionally or alternatively, the plurality of pulses of each of the sequences includes a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity. The first intensity and the last intensity may be the same. Thus, the intensity of the intermediate pulse between the maximum pulse and the last pulse preferably decreases from the maximum pulse to the last pulse. By reducing the intensity in each sequence towards the end of the sequence, the patient's tissue, e.g. the diaphragm, may be more naturally activated, so that comfort may be further improved.

As described above, each single pulse of the plurality of pulses typically has a pulse time width, wherein the pulse time width may be substantially the same for all pulses. Preferably, said pulse time width comprises an increasing portion, in which said intensity increases, and/or a decreasing portion, in which said intensity decreases. In case the spatial field is an electromagnetic field, noise may be generated due to the relatively large electromagnetic forces between the coil windings of the electromagnetic field generator that may be involved during the pulse, which forces affect the coil in an impact equivalent to a bump with a baton. This noise can cause discomfort to the patient and surrounding people. However, by providing a single pulse with increasing and/or decreasing portions, the final intensity can be built up and decreased more and more. In this way, the noise caused by a single pulse can be substantially reduced. This may improve comfort during activation of the patient.

The increasing and decreasing portions of a single pulse may be established by providing a plurality of sub-pulses of different intensities. Such sub-pulses may in particular be high frequency sub-pulses. More specifically, the increasing portion of a single pulse may be established by a plurality of sub-pulses having increasing intensities. Conversely, the decreasing portion of a single pulse may be established by a plurality of sub-pulses having decreasing intensity.

In order to achieve a satisfactory degree of noise reduction, the increased portion and in particular the decreased portion together preferably cover at least 60% of the pulse time width or at least 80% of the pulse time width. In particular, the intensity of each single pulse may describe a clock-like shape.

Preferably, each of said sequences comprises a cumulative intensity calculated by summing the intensities of its pulses, wherein said cumulative intensities of said sequences are different. There may also be sequences with the same cumulative intensity. However, in general, the cumulative intensity of at least two, preferably more, of the sequences will be different.

Thus, the sequences preferably comprise a first sequence having a first integrated intensity and a maximum sequence having a maximum integrated intensity, wherein the maximum integrated intensity is higher than the first integrated intensity. More specifically, the sequences may have a plurality of increasing sequences in which the cumulative intensity increases from the first cumulative intensity to the maximum cumulative intensity. By increasing the integrated intensity from a first integrated intensity to a maximum integrated intensity, advantageously by gradually increasing the integrated intensity from one sequence to the next, a rather high integrated intensity can be provided to the patient without causing discomfort. Instead, the patient may be adjusted to a maximum cumulative intensity. This allows for providing effective activation involving a relatively high intensity without substantial discomfort or adverse reactions, such as jerking.

Preferably, each of said sequences comprises the same number of pulses. Additionally or alternatively, each of the sequences includes substantially the same sequence temporal width. Thus, the sequence time width is preferably in the range of about 0.5 seconds to about 1.5 seconds. Such a configuration allows for the provision of a stable stimulus that may reduce patient discomfort or surprise resulting in a counter reaction (e.g., a sudden twitch).

Preferably, the sequence comprises about 10 to about 20 sequences per minute. It has been shown that such a sequence frequency is effective to stimulate the target tissue and thus to activate the patient in a comfortable manner.

Further, the plurality of pulses of the sequence preferably includes a frequency in a range of about 15 hertz to about 25 hertz. Providing pulses at such a frequency may enable efficient stimulation. The combination of the above sequence frequency with the pulse frequency may be particularly advantageous.

In another aspect, the present invention is a method of manufacturing a stimulation device. The manufacturing process comprises the following steps: (ii) providing a sensing device having a field generator configured to generate a spatial field having a target shape, (ii) configuring the sensing device to be placed at a human or animal patient such that upon activation of the patient, target tissue is stimulated by the spatial field generated by the coil design, (iii) providing a control unit adapted to communicate with the sensing device, (iv) configuring the control unit to control the sensing device to generate the spatial field, and (v) configuring the control unit to operate the sensing device such that the field generator generates a train of continuous sequences of a plurality of pulses of the spatial field, wherein the sequences are intermittent.

The manufacturing process according to the invention allows to provide the stimulation device according to the invention described above. In this way, the effects and benefits described above in connection with the stimulation device may be effectively achieved. Furthermore, the effects and benefits described above in connection with the preferred features of the stimulation device may be achieved by the following additional steps and features of the manufacturing process.

The preferred steps are as follows: configuring the control unit to operate the sensing device such that the field generator generates the plurality of pulses of each of the sequence, the plurality of pulses including a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity. Thereby, the intensity of the intermediate pulse between the first pulse and the maximum pulse may be increased from the first pulse to the maximum pulse. Further, the plurality of pulses of each of the sequence may include a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensity of an intermediate pulse between the maximum pulse and the last pulse decreases from the maximum pulse to the last pulse.

The preferred steps are as follows: the control unit is configured to operate the sensing device such that the field generator produces each of the sequences having cumulative intensities calculated by summing the intensities of its pulses, wherein the cumulative intensities of the sequences are different. Thus, the sequences may comprise a first sequence having a first integrated intensity and a maximum sequence having a maximum integrated intensity, wherein the maximum integrated intensity is higher than the first integrated intensity.

The preferred steps are as follows: the control unit is configured to operate the induction device such that the field generator generates each of the sequences having the same number of pulses.

The preferred steps are as follows: the control unit is configured to operate the sensing device such that the field generator produces each of the sequences with substantially the same sequence temporal width. Thus, the sequence time width is in the range of about 0.5 seconds to about 1.5 seconds.

The preferred steps are as follows: the control unit is configured to operate the sensing device such that the field generator generates the sequences at a rate of about 10 to about 20 sequences per minute.

The preferred steps are as follows: configuring the control unit to operate the sensing device such that the field generator generates each of the plurality of pulses of the sequence having substantially the same pulse time widths. Thus, the pulse time width is in the range of about 160 microseconds to about 220 microseconds. Furthermore, the pulse time width comprises an increasing portion, in which the intensity is increased, and/or a decreasing portion, in which the intensity is decreased, wherein the increasing portion and the decreasing portion together preferably cover at least 60% of the pulse time width.

The preferred steps are as follows: configuring the control unit to operate the sensing device such that the field generator generates the plurality of pulses having the sequence of frequencies in a range of about 15 Hertz to about 25 Hertz.

In a preferred embodiment, the field generators of the provided induction device comprise electrodes, and the spatial fields generated by the field generators are electric fields.

In another preferred embodiment, the field generator of the provided induction device comprises a coil design and the spatial field generated by the field generator is an electromagnetic field.

In another aspect, the invention is a method of activating a human or animal patient by stimulating a target tissue of the human or animal patient. The activation method comprises the following steps: obtaining (a) a sensing device having a field generator configured to generate a spatial field having a target shape and a control unit in communication with the sensing device and configured to control the sensing device to generate a spatial field, (b) positioning the field generator of the sensing device at the patient such that the target tissue is stimulated by the spatial field generated by the coil design, and (c) operating the sensing device such that the field generator generates a train of continuous sequences of a plurality of pulses of the spatial field, wherein the sequences are intermittent.

The activation method according to the invention allows to effectively achieve the effects and benefits described above in connection with the stimulation device. Advantageously, therefore, such a stimulation device is used for applying the activation method or at least parts thereof.

Preferably, the target tissue is the patient's phrenic nerve and activating the patient is activating the patient's diaphragm. As such, the method may be used to ventilate a patient or to assist in ventilating a patient. In these applications, the present invention is particularly beneficial.

More specifically, the activation method preferably includes the steps of: the method includes connecting a conduit interface to a respiratory system of the patient, delivering air to the respiratory system of the patient through the conduit interface, controlling the delivery of air to the respiratory system of the patient according to a breathing regime, and activating the diaphragm of the patient in coordination with the breathing regime. This implementation of the activation method may provide effective mechanical ventilation assistance and prevent or reduce the risk of side effects, such as development of Acute Respiratory Distress Syndrome (ARDS) or Ventilator Associated Pneumonia (VAP) or Ventilator Induced Lung Injury (VILI).

The effects and benefits described above in connection with the preferred features of the stimulation device may be achieved by the following additional steps and features of the activation method.

Preferably, the plurality of pulses of each of the sequence generated by the field generator of the induction device comprises a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity. Thus, the intensity of the intermediate pulse between the first pulse and the maximum pulse rises from the first pulse to the maximum pulse. Further, the plurality of pulses of each of the sequence includes a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensity of a middle pulse between the maximum pulse and the last pulse decreases from the maximum pulse to the last pulse.

Preferably, each of said sequences comprises a cumulative intensity calculated by summing the intensities of its pulses, wherein said cumulative intensities of said sequences are different. Thus, each of the sequences comprises a first sequence having a first integrated intensity and a maximum sequence having a maximum integrated intensity, wherein the maximum integrated intensity is higher than the first integrated intensity.

Preferably, each of said sequences comprises the same number of pulses.

Preferably, each of the sequences comprises substantially the same sequence temporal width. Thus, the sequence time width is preferably in the range of about 0.5 seconds to about 1.5 seconds.

Preferably, the sequence comprises about 10 to about 20 sequences per minute.

Preferably, each of the plurality of pulses of the sequence comprises substantially the same pulse time width. Accordingly, the pulse time width is preferably in the range of about 160 microseconds to about 220 microseconds. Furthermore, the pulse time width preferably comprises an increasing portion, in which the intensity increases, and/or a decreasing portion, in which the intensity decreases, wherein the increasing portion and the decreasing portion together preferably cover at least 60% of the pulse time width.

Preferably, the plurality of pulses of the sequence comprise a frequency in a range of about 15 hertz to about 25 hertz.

In a preferred embodiment, the field generators of the induction device used in the method comprise electrodes, and the spatial fields generated by the field generators are electric fields.

In another preferred embodiment, the field generators of the induction device used in the method comprise a coil design and the spatial fields generated by the field generators are electromagnetic fields.

In another aspect, the invention is a computer program comprising instructions which, when executed by a control unit, cause the control unit to operate a field generator of a sensing device positioned at a human or animal patient, to cause target tissue of the patient to be stimulated by a spatial field generated by a coil design of the field generator of the sensing device, such that the field generator generates a train of continuous sequences of a plurality of pulses of the spatial field, wherein the sequences are intermittent.

The computer program may be a computer program product comprising computer code means configured, when executed on the control unit, to control a processor of a computer to implement the steps and/or features described above or below. Furthermore, a computer-readable medium may be provided comprising instructions which, when executed by a computer or control unit, cause the computer or control unit to perform the steps and/or features described above or below. The medium may be a storage medium and, for ease of distribution, may be a mobile or portable storage medium. Alternatively, a data carrier signal carrying the computer program as described hereinbefore may be provided for allowing transmission over the internet or the like, or for other purposes. The computer program may also be referred to as or consist of software.

The computer program according to the invention allows to effectively achieve the effects and benefits described above in connection with the stimulation device. Thereby, advantageously, such a stimulation device or at least parts thereof (like the control unit thereof) participate in executing the computer program.

The following advantageous embodiments of the computer program according to the present invention are described which allow to achieve the effects and benefits described above in connection with the preferred embodiments of the stimulation device.

Preferably, the plurality of pulses of each of the sequence comprises a first pulse having a first intensity and a maximum pulse having a maximum intensity, wherein the maximum intensity is higher than the first intensity. Thus, wherein the intensity of the intermediate pulse between the first pulse and the maximum pulse increases from the first pulse to the maximum pulse. Further, the plurality of pulses of each of the sequence includes a last pulse having a last intensity, wherein the last intensity is lower than the maximum intensity, wherein the intensity of a middle pulse between the maximum pulse and the last pulse decreases from the maximum pulse to the last pulse.

Preferably, each of said sequences comprises the same number of pulses.

Preferably, the sequence comprises about 10 to about 20 sequences per minute.

In a preferred embodiment of the computer program, the field generators of the induction device comprise electrodes and the spatial fields generated by the field generators are electric fields.

In a further preferred embodiment of the computer program, the field generators of the induction device comprise a coil design and the spatial fields generated by the field generators are electromagnetic fields.

Drawings

A stimulation device according to the invention, a process for manufacturing such a stimulation device according to the invention, a method for activating a patient according to the invention and a computer program for controlling the activation of a patient according to the invention are described in more detail below by means of exemplary embodiments and with reference to the accompanying drawings, in which:

fig. 1 shows a schematic view of an embodiment of a stimulation device according to the invention implemented in a ventilation device, manufactured by a process according to the invention, implementing an embodiment of a method according to the invention, and running a computer program according to the invention;

FIG. 2 shows a first embodiment of the provision of an electromagnetic field sequence according to the invention;

FIG. 3 shows a second embodiment of the provision of an electromagnetic field sequence according to the invention; and

figure 4 shows a single pulse of a third embodiment provided by the electromagnetic field sequence.

Detailed Description

In the following description, certain terminology is used for convenience and is not intended to be limiting of the invention. The terms "right," "left," "upper," "lower," "below," and "above" refer to directions in the drawings. The terminology includes the words specifically mentioned, derivatives thereof, and words of similar import. Furthermore, spatially relative terms, such as "under," "below," "beneath," "over," "above," "proximal" and "distal," may be used to describe one element or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the device in use or operation in addition to the position and orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both a position and an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, descriptions of motion along and about various axes include various specific device positions and orientations.

To avoid repetition in the figures and description of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from the description or drawings is not meant to imply the absence of such aspect in embodiments incorporating such aspect. Rather, this aspect may be omitted for clarity and to avoid a lengthy description. In this case, the following applies to the rest of the description: if reference numerals, which are not explained in directly related parts of the specification, are included in the drawings for clarity of the drawings, they should be referred to in the foregoing or following description. Moreover, for the sake of clarity, if not all features of a component are provided with a reference numeral in a figure, it shall refer to other figures showing the same component. The same reference numbers in two or more drawings identify the same or similar elements.

Fig. 1 shows an embodiment of a stimulation device 1 according to the invention implemented as a ventilation device. The stimulation device 1 includes a ventilator 6, an electromagnetic induction device 2 (hereinafter also referred to as an EMI device) as an induction device, a control unit 3, and a sensor 4. The EMI device 2 comprises an electromagnetic field generator 21 as a magnetic field generator with two coils 211 as a coil design. The coils 211 lie in a common plane and are configured to generate spatial electromagnetic fields 212 as spatial fields. When operated, the two coils 211 generate an electromagnetic field towards the neck 52 of the patient 5. The electromagnetic field has a central target shape with the electromagnetic field at its focal region extending maximally into the neck 52. Further, the EMI device 2 has a mounting device 22 with a neck arc 221 that is disposed at the neck 52 of the patient 5 and secured to the bed 51 on which the patient 5 is lying. The neck arc 221 is equipped with a connector 222 as a reset feature for the electromagnetic field adjustment mechanism of the EMI device 2. The connector 222 secures the coil 211 to the neck 52 of the patient 5.

Ventilator 6 includes a ventilator 61 as a flow generator, a breather tube 63 extending from ventilator 61, and a mouthpiece 62 as a conduit interface. The mouthpiece 62 is a tube that enters the respiratory system of the patient 5 through the patient's mouth.

The control unit 3 has a user interface 31 for exchanging information with a healthcare practitioner who supervises or sets the ventilation of the patient 5. For example, the user interface 31 may be implemented as a touch screen that allows input and output of information. Furthermore, the control unit 3 is equipped with a device interface 32, which device interface 32 is arranged to be coupled to the interface units of the EMI device 2, the sensor 4 and the ventilator 6 by means of wires 33. In this way, the control unit 3 communicates with the ventilator 6, the EMI device 2 and the sensor 4.

More specifically, the control unit 3 is configured to receive ventilation data from the ventilator 6 regarding the ventilation of the patient 5 and to control the EMI device 2 to generate a spatial electromagnetic field in accordance with the evaluated ventilation data, as described in more detail below. Furthermore, the control unit 3 is configured to manipulate the joint 222 to automatically change the position of the focal region 213 of the spatial electromagnetic field 212 generated by the coil 211 and to change the field strength of the spatial electromagnetic field 212. The purpose of varying the field strength and the position of the spatial electromagnetic field 212 is to adapt the spatial electromagnetic field 212 such that it specifically stimulates the phrenic nerve of the patient 5. Upon stimulation of the phrenic nerve 53, the diaphragm of the patient 5 is activated. Thereby creating a flow of gas or breath.

The ventilator 6 is configured to mechanically ventilate the patient 5 by pushing air into the respiratory system of the patient 5 through the mouthpiece 62. More specifically, the respirator 61 is configured to deliver air through the mouthpiece 62. The control unit 3 is configured to control the ventilator 61 to deliver air according to a breathing scheme defined in the control unit 3. Furthermore, the control unit 3 regulates the activation of the diaphragm in coordination with the breathing regime so as to coordinate with the ventilation of the patient 5 by the activation of the diaphragm of the phrenic nerve 53.

In order to be able to provide various treatments during ventilation, the control unit 3 has a computer executing a computer program which configures the control unit 3 to define combinations of stimulation durations and repetition frequencies and to operate the EMI device 2 according to the defined stimulation durations and the determined repetition frequencies. Thus, the control unit 3 provides the physician with treatment options via the user interface 31. The physician selects the appropriate treatment and sets the relevant parameters.

To prevent loss of the diaphragm and/or reduce the risk of VIDD, a first mode of operation is set in the control unit 3 by defining a stimulation duration in the range of about 3 minutes to about 20 minutes, and a repetition frequency in the range of about once a day to about 3 times a day.

In order to reduce the risk of occurrence of ARDS, a second mode of operation is set in the control unit 3 by defining a repetition frequency in the range of about twice per hour to about twice per two hours and a stimulation duration in the range of about 0.5 minutes to about 3 minutes.

In order to reduce the risk of occurrence of ARDS, a third operating mode is set in the control unit 3 by defining a stimulation duration in the range of about 1 to about 5 respiratory cycles and a repetition frequency in the range of about every minute to about every 30 minutes.

In order to induce a breathing cycle or to stimulate deep breathing, a fourth operating mode is provided in the control unit 3. In a fourth mode of operation, the control unit 3 evaluates the oxygen level or the carbon dioxide level in the blood of the patient 5 measured by the sensor 4 and compares it with a predefined threshold value. Then, when the measured oxygen level or carbon dioxide level exceeds a predefined threshold, the control unit 3 operates the EMI device 2. The control unit 3 operates the EMI means 2, in particular when the measured oxygen level is below a threshold value or when the measured carbon dioxide level is above a threshold value.

Furthermore, by executing the computer program, the control unit 3 is configured to operate the EMI apparatus 2 such that the electromagnetic field generator 21 generates a train of consecutive sequences (trains) of a plurality of pulses of the spatial electromagnetic field, wherein the sequences are discontinuous.

As shown in fig. 2, in a first embodiment, the control unit 3 operates the EMI device 2 such that the electromagnetic field generator 21 generates a series of sequences 7, wherein each sequence 7 comprises a set of four electromagnetic field pulses 8 with a pulse time width 84 of 160 microseconds (μ s). Sequence 7 has a uniform sequence time width 74 of 0.5 seconds. Sequence 7 has a uniform break between 2 seconds and 5 seconds.

The single pulses 8 of each sequence 7 have the same intensity I. More specifically, the first sequence 71 comprises a first intensity I ₁ Of the four first pulses 81, the second sequence 72 comprises pulses having a second intensity I ₂ The third maximum sequence 73 comprises four second pulses 82 having a third maximum intensity I ₃ Four pulses 83. Each of the sequences 7 comprises a cumulative intensity calculated by summing the intensities of its pulses 7. Thus, by four first intensities I of the first pulse 81 thereto ₁ And summed to calculate a first cumulative intensity for the first sequence 71. Accordingly, by subjecting it toFour second intensities I of two pulses 82 ₂ The second cumulative intensity of the second sequence 72 is calculated by summing and the four maximum intensities I of its maximum pulses 83 are summed ₃ The sum is used to calculate the maximum cumulative intensity of the maximum sequence 73. Thus, the cumulative intensities of the series 7 are different, the first cumulative intensity of the first series 71 being lower than the second cumulative intensity of the second series 72, the second cumulative intensity of the second series 72 being lower than the maximum cumulative intensity of the maximum series 73.

The patient 5 is adjusted to the maximum cumulative intensity by gradually increasing the cumulative intensity from one series 7 to the next. In this way, acceptance can be improved and adverse reactions of the patient 5 can be prevented.

As shown in fig. 3, in a second embodiment, the control unit 3 operates the EMI device 2 such that the electromagnetic field generator 21 generates electromagnetic pulses 70, wherein each sequence 701 comprises a set of 20 electromagnetic field pulses. In particular, the sequence 70 comprises a first pulse 801 having a first intensity, followed by a second pulse 802 having a second intensity higher than the first intensity, followed by a third pulse 803 having a third intensity higher than the second intensity, followed by fourteen maximum pulses 804 having a maximum intensity higher than the third intensity, followed by another third pulse 803, followed by another second pulse 802, followed by another first pulse 801. The sequence 701 has a sequence time width of 1 s.

The patient 5 is adjusted to a maximum intensity by stepping up the intensity within each single pulse sequence 701 from the first pulse 801 to the second pulse 802, to the third pulse 803 and to the maximum pulse 804. This may increase acceptance of each sequence 701 and may prevent adverse reactions, such as jerks, in the patient 5.

As shown in fig. 4, in the third embodiment, the control unit 3 operates the EMI device 2 such that the electromagnetic field generator 21 generates a single pulse 800 containing high-frequency sub-pulses. Each pulse 800 comprises a set of five sub-pulses of the electromagnetic field. More specifically, each pulse comprises a first sub-pulse 811 having a first intensity, followed by a second sub-pulse 812 having a second intensity higher than the first intensity, followed by a third sub-pulse 813 having a third intensity higher than the second intensity, followed by a maximum sub-pulse 814 having a maximum intensity higher than the third intensity, followed by another third sub-pulse 813, followed by another second sub-pulse 812, followed by another first sub-pulse 801. The sub-pulses form the bell-shaped intensity 810 of the pulse. Each of the pulses has a pulse time width 840 of 160 mus. The first, second and

largest sub-pulses

811, 812, 813 at the beginning of the pulse 800 form an increasing part of the pulse 800. The third, second, first sub-pulses 813, 812, and 822 at the end of pulse 800 form the reduced portion of pulse 800.

The patient 5 is adjusted to the intensity of each single pulse by increasing the intensity within each single pulse 800 in its increasing part from the first sub-pulse 811, the second sub-pulse 812 and the third sub-pulse 813 to the maximum sub-pulse 814. In this way, the acceptance of each pulse 800 may be increased, which may provide higher pulse strengths. Furthermore, by stepping down the intensity within each single pulse 800 in its decreasing part from the largest sub-pulse 814 to the third sub-pulse 813, the second sub-pulse 812 and the first sub-pulse 811, the generation of noise may be substantially reduced. In this way, the acceptance of stimulation therapy can be further increased.

The description and drawings illustrating aspects and embodiments of the invention should not be taken as limiting the claims to the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of the description and claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. It will therefore be appreciated that those skilled in the art will be able to make variations and modifications within the scope and spirit of the following claims. In particular, the invention covers other embodiments having any combination of the features of the different embodiments described above and below. For example, the invention may be operated in the following examples, in which:

the provision of pulses within a single sequence as shown in fig. 3 in combination with the adjustment of the cumulative intensity of the sequence as shown in fig. 2, and/or

The pulse provision of pulse intensity with a clock or similar shape shown in fig. 4 is combined with the pulse provision within a single sequence shown in fig. 3 and/or the adjustment of the cumulative intensity of the sequence shown in fig. 2.

The present disclosure also encompasses all other features shown in the various figures, even though they may not have been described in the foregoing or the following description. Furthermore, single alternatives and descriptions of features thereof and single alternatives of the embodiments described in the figures may be excluded from the subject matter of the invention or the disclosed subject matter. The present disclosure includes subject matter consisting of, and including the features defined in the claims or exemplary embodiments.

In addition, in the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may fulfill the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms "substantially", "about", "approximately", and the like in relation to an attribute or value also accurately define the attribute or value, respectively. In the context of a given value or range, the term "about" refers to a value or range that is within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be directly coupled, electrically or mechanically, or indirectly coupled through one or more intervening components. Any reference signs in the claims shall not be construed as limiting the scope.

A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the internet or other wired or wireless telecommunication systems. In particular, the computer program may be, for example, a computer program product stored on a computer-readable medium, which may have computer-executable program code adapted to be executed to implement a particular method, such as a method according to the present invention. Furthermore, the computer program may also be a data structure product or a signal for implementing a particular method, such as a method according to the invention.

Claims

1. A stimulation device (1) comprising

An induction device (2) having a field generator (21) configured to generate a spatial field having a target shape, and

a control unit (3) which is in communication with the induction device (2) and is configured to control the induction device (2) to generate the spatial field, wherein

The field generators (21) of the induction device (2) are configured to be placed at a human or animal patient (5) such that upon activation of the patient (5) target tissue is stimulated by the spatial fields generated by the field generators (21),

characterized in that the control unit (3) is configured to operate the induction device (2) such that the field generator (21) generates a train of consecutive sequences (7.

2. The stimulation device (1) according to claim 1, wherein the plurality of pulses (8.

3. The stimulation device (1) according to claim 2, wherein the intensity of the intermediate pulses (802, 803) between the first pulse (801) and the maximum pulse (804) increases from the first pulse (801) to the maximum pulse (804).

4. The stimulation device (1) according to claim 2 or 3, wherein the plurality of pulses (8.

5. The stimulation device (1) according to claim 4, wherein the intensity of the intermediate pulses (803, 802) between the maximum pulse (804) and the last pulse (801) decreases from the maximum pulse (804) to the last pulse (801).

6. The stimulation device (1) according to any one of the preceding claims, wherein each of the sequences (7.

7. The stimulation device (1) according to claim 6, wherein the sequence (7.

8. The stimulation device (1) according to any one of the preceding claims, wherein each of the sequences (7.

9. The stimulation device (1) according to any one of the preceding claims, wherein each of the sequences (7.

10. The stimulation device (1) according to claim 9, wherein the sequence time width (74.

11. The stimulation device (1) according to any one of the preceding claims, wherein the sequence (7.

12. The stimulation device (1) according to any one of the preceding claims, wherein each of the plurality of pulses (8.

13. The stimulation device (1) according to claim 12, wherein the pulse time width (84.

14. The stimulation device (1) according to claim 12 or 13, wherein the pulse time width (84.

15. The stimulation device (1) according to claim 14, wherein the increasing portion and the decreasing portion together cover at least 60% of the pulse time width (84.

16. The stimulation device (1) according to any one of the preceding claims, wherein the plurality of pulses (8.

17. A stimulation device according to any of the preceding claims, wherein the field generator of the sensing device comprises an electrode and the spatial field generated by the field generator is an electric field.

18. A stimulation device according to any one of claims 1-16, wherein the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electromagnetic field.

19. A method of making a stimulation device comprising

Providing an induction device (2) having a field generator (21) configured to generate a spatial field having a target shape,

configuring the sensing device (2) to be placed at a human or animal patient (5) such that upon activation of the patient (5) target tissue is stimulated by the spatial field generated by the field generator (21),

providing a control unit (3) adapted to communicate with the sensing means,

the control unit (3) is configured to control the induction device (2) to generate the spatial field, an

-configuring the control unit (3) to operate the induction device (2) such that the field generator (21) generates a train of consecutive sequences (7.

20. A method of activating a human or animal patient (5) by stimulating target tissue of the human or animal patient (5), comprising

Obtaining an induction device (2) having a field generator (21) with a coil design (211) configured to generate a spatial field having a target shape, and obtaining a control unit (3) in communication with the induction device (2) and configured to control the induction device (2) to generate the spatial field,

positioning the field generator (21) of the induction device (2) at the patient (5) such that the target tissue is stimulated by the spatial field generated by the field generator (21),

operating the induction device (2) such that the field generator (21) generates a train of consecutive sequences (7.

21. The method of claim 20, wherein the target tissue is the phrenic nerve of the patient (5) and activating the patient (5) is activating the patient's diaphragm.

22. The method of claim 21, comprising

Connecting a catheter interface to the respiratory system of the patient (5),

delivering air to the respiratory system of the patient (5) through the catheter interface,

controlling the delivery of air to the respiratory system of the patient (5) in accordance with a breathing regime, an

Activating the diaphragm of the patient (5) to coordinate with the breathing regime.

23. The method according to any one of claims 20 to 22, wherein the plurality of pulses (8.

24. The method of claim 23, wherein the intensity of an intermediate pulse between the first pulse and the maximum pulse increases from the first pulse to the maximum pulse.

25. The method of claim 23 or 24, wherein the plurality of pulses (8.

26. The method of claim 25, wherein the intensity of a middle pulse between the largest pulse and the last pulse decreases from the largest pulse to the last pulse.

27. The method according to any one of claims 20 to 26, wherein each of the sequences (7.

28. The method of claim 27, wherein each of the sequences (7.

29. The method according to any one of claims 20 to 28, wherein each of said sequences (7.

30. The method according to any one of claims 20 to 29, wherein each of the sequences (7.

31. The method of claim 30, wherein the sequence temporal width is in a range from about 0.5 seconds to about 1.5 seconds.

32. The method according to any one of claims 20 to 31, wherein the sequence (7.

33. The method according to any one of claims 20 to 32, wherein each of the plurality of pulses (8.

34. The method of claim 33, wherein the pulse time width is in a range of about 160 microseconds to about 220 microseconds.

35. The method of claim 33 or 34, wherein the pulse time width comprises an increasing portion in which the intensity increases and/or a decreasing portion in which the intensity decreases.

36. The method of claim 35, wherein the increasing portion and the decreasing portion collectively cover at least 60% of the pulse time width.

37. The method according to any one of claims 20 to 36, wherein the plurality of pulses (8.

38. The method of any one of claims 20 to 37, wherein the field generator of the induction device comprises an electrode and the spatial field generated by the field generator is an electric field.

39. The method of any one of claims 20 to 38, wherein the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electromagnetic field.

40. A computer program comprising instructions which, when executed by a control unit, cause the control unit (3) to operate a field generator (21) of a sensing device (2) placed at a human or animal patient (5), cause target tissue of the patient (5) to be stimulated by a spatial field generated by the field generator (21) of the sensing device, such that the field generator (21) generates a train of consecutive sequences (7.

41. The computer program of claim 40, wherein the plurality of pulses (8.

42. The computer program of claim 41, wherein the intensity of an intermediate pulse between the first pulse and the maximum pulse rises from the first pulse to the maximum pulse.

43. The computer program according to claim 41 or 42, wherein the plurality of pulses (8.

44. The computer program of claim 43, wherein the intensity of a middle pulse between the largest pulse and the last pulse decreases from the largest pulse to the last pulse.

45. The computer program of any one of claims 40 to 44, wherein each of the sequences (7.

46. The computer program according to claim 45, wherein each of the sequences (7.

47. The computer program according to any of claims 40 to 46, wherein each of the sequences (7.

48. The computer program of any one of claims 40 to 47, wherein each of the sequences (7.

49. The computer program of claim 48, wherein the sequence temporal width is in a range of about 0.5 seconds to about 1.5 seconds.

50. The computer program according to any one of claims 40 to 49, wherein the sequence (7.

51. The computer program of any one of claims 40 to 50, wherein each of the plurality of pulses (8.

52. The computer program of claim 51, wherein the pulse time width is in a range of about 160 microseconds to about 220 microseconds.

53. A computer program according to claim 51 or 52, wherein the pulse time width comprises an increasing portion in which the intensity increases, and/or a decreasing portion in which the intensity decreases.

54. The computer program of claim 53, wherein the increasing portion and the decreasing portion collectively cover at least 60% of the pulse time width.

55. The computer program according to any one of claims 40 to 55, wherein the plurality of pulses (8.

56. The computer program of any one of claims 40 to 55, wherein the field generators of the inductive device comprise electrodes and the spatial fields generated by the field generators are electric fields.

57. The computer program according to any one of claims 40 to 56, wherein the field generators of the induction device comprise a coil design and the spatial fields generated by the field generators are electromagnetic fields.